Metabolic Syndrome
Conditions
Brief summary
The goal of this single-blind randomized placebo-controlled trial is to test the effects of an oral ketone supplement on appetite, cognition, metabolism, and cardiovascular function in individuals with obesity and insulin resistance. The main question\[s\] it aims to answer are: * Does taking the ketone supplement reduce appetite and improve cognition? * How does the ketone supplement alter metabolism and cardiovascular function? Participants will be asked to consume a randomly assigned ketone ester supplement or a placebo and testing will be done to see how the supplement affects the following compared to a placebo: * appetite, * cognition, * metabolism * cardiovascular function Researchers will compare individuals with obesity and insulin resistance to individuals with normal weight and no insulin resistance to see if the ketone supplement affects groups differently.
Interventions
DIETARY_SUPPLEMENTKetone Ester Supplement
Oral ingestion of a ketone supplement combined with a flavoring agent and diluted in water
OTHERPlacebo
Oral ingestion of cellulose combined with a flavoring agent and diluted in water
Sponsors
University of Southern Mississippi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults between the ages of 18-50 years of age. * Presence of metabolic sydnrome Control Participant Eligibility: * A waist circumference of \< 102 cm for males and \< 88 cm for females, and * No indication of metabolic syndrome
Exclusion criteria
* Pregnant * Breastfeeding or lactating * Missing any limbs or part of a limb * Having a substantial amount of metal implants (metal plates or complete joint replacements) * Having a pacemaker or any other electrical implant * Type I diabetes * Gestational diabetes * Taking insulin * Any history of severe traumatic brain injury or mild traumatic brain injury within the last two years * Kidney disease * Liver disease * Thyroid disease * Any diagnosed neurological or neurodegenerative diseases * Any surgeries that would impact swallowing and/or digestion * Being on a ketogenic diet or having been on a ketogenic diet in the last 6 months * Having received ionizing radiation from a medical procedure within the last 30 days * Being on a medically prescribed diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digit Span Test - Digital Cognitive Function Test | Baseline, 75 minutes | Changes in Digit Span Test score |
| Desire to eat - Visual Digital Analog Scale (0-100) | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion | Changes in subjective rating of desire to eat |
| Prospective consumption of food - Visual Digital Analog Scale (0-100) | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion | Changes in subjective rating of prospective consumption of food |
| Thirst - Visual Digital Analog Scale (0-100) | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion | Changes in subjective rating of thirst |
| Stroop Test - Digital Cognitive Function Test | Baseline, 75 minutes | Changes in Stroop score |
| Go/No-go Test - Digital Cognitive Function Test | Baseline, 75 minutes | Changes in Go/No-go score |
| Task Switching Task - Digital Cognitive Function Test | Baseline, 75 minutes | Changes in Task Switching Task score |
| Number Back Test - Digital Cognitive Function Test | Baseline, 75 minutes | Changes in Number Back Test score |
| Blood pressure | Baseline (pre-ingestion) | Blood pressure responses (systolic and diastolic) to sympathoexcitation |
| Heart Rate | Baseline (pre-ingestion) | Heart rate responses to sympathoexcitation |
| Heart Rate Variability | Baseline (pre-ingestion) | Index of cardiac autonomic control |
| Cardiac Baroreflex Sensitivity | 105 minutes post ingestion | Changes in cardiac interval relative to changes in systolic blood pressure |
| Hunger - Visual Digital Analog Scale (0-100) | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion | Changes in subjective rating of hunger |
| Fullness - Visual Digital Analog Scale (0-100) | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion | Changes in subjective rating of fullness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Blood Flow | Baseline, 30, 60 and 90 minutes post ingestion | Doppler Ultrasound of Femoral Artery |
| Peripheral Vascular Conductance | Baseline, 30, 60 and 90 minutes post ingestion | Blood flow normalized to blood pressure (mL/min/mmHg) |
| Blood ketones | Baseline, 30, 60, 90, 120 minutes post ingestion | Ketone body level from capillary blood |
| Blood glucose | Baseline, 30, 60, 90, 120 minutes post ingestion | Blood glucose level from capillary blood |
| Oxygen Consumption from Respiratory Gases | Baseline and continuous for 120 minutes | Amount of oxygen consumed using indirect calorimetry |
| Carbon Dioxide Produced from Respiratory Gases | Baseline and continuous for 120 minutes | Amount of carbon dioxide produced using indirect calorimetry |
| Prefrontal Cortex Oxygenation | Baseline, 90 minutes post ingestion | Near-infrared spectroscopy |
Countries
United States
Outcome results
None listed